FDA publishes two more DSCSA guidance documents

The FDA has published further guidance to help the pharma industry meet the 2023, deadline for implementing the Drug Supply Chain Security Act (DSCSA), focusing on standards and trading partners.

The DSCSA was enacted in 2013 to boost the FDA's ability to protect US patients by developing a connected, digital system to trace prescription drugs throughout the country and identify counterfeit, stolen or contaminated medicine before it reaches the hands of consumers.

The overall aim is to make sure that prescription drugs subject to the DSCSA are properly stored, handled, and transported, and to reduce the risk of drugs that may be counterfeit, stolen, contaminated, or otherwise harmful entering the supply chain.

The first document – DSCSA Standards for the Interoperable Exchange of Information for Tracing of Certain Human, Finished, Prescription Drugs – is an update on an earlier version first issued way back in 2014.

The new draft is intended to take into account the looming date of November 27 next year, when the "enhanced drug distribution security requirements" of the DSCSA to come into effect.

It has been updated to reflect changes, including that paper-based tracing of medicines will no longer be permitted from that date and verification of product at the package level will be required, unless a "waiver, exception, or exemption" applies.

The document comes out firmly in favour of the Electronic Product Code Information Services (EPCIS) standard developed by GS1 to provide and maintain the data associated with transaction information as medicines travel through the supply chain, while the earlier versions did not specify a format.

That reticence has held back implementation of EPCIS by pharma trading partners, according to the Healthcare Distribution Alliance (HDA) industry body, which has kept tabs on adoption of the standard through a regular benchmarking survey.

It's latest report, in March, indicated that while many pharma manufacturers have made progress to exchange data via EPCIS, very few are sending it in production. Something blamed in part on a lack of guidance from the FDA.

The poll of 40 manufacturers, 16 distributors and four third-party logistics providers found that ore than two thirds of manufacturers (69 per cent) plan to use a third party to connect, up seven points on the prior survey.

Just 38 per cent of distributors had yet to connect via EPCIS, although for two thirds this is still in process – a situation blamed on "lack of trading partner commitment."

The second new guidance – Identifying Trading Partners Under the Drug Supply Chain Security Act – revises a 2017 guidance on how trading partners in the supply chain can be categorised, and " help clarify for industry whether they are engaged in activities that require licensure and annual reporting."

It has been updated to reflect the agency's current thinking on the status of certain entities such as "private label distributors, salvagers, and returns processors and reverse logistics providers."

It also covers some specific drug distribution scenarios, including "distribution for emergency medical use, office use, non-human research purposes, and research in humans under an investigational new drug application."